ClinicalTrials.gg
CompletedNCT04508699Updated Dec 13, 2024Results posted

Semantic Learning Deficits in School Age Children With Developmental Language Disorder

An interventional study of semantic learning in Developmental Language Disorder, sponsored by San Diego State University. Completed at 1 site in United States. Open to participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by San Diego State University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Non-randomized
Ages
10 Years to 12 Years
Sex
All
01

Study summary

School age children with developmental language disorder (DLD) have known semantic learning deficits but what is less well understood is why semantic learning is difficult for these children. This project will combine behavioral and brain methods to investigate the cognitive and linguistic processes underlying semantic learning in children with DLD compared to typically developing peers. The outcomes will have implications for semantic learning intervention approaches in DLD.

Read the detailed description

This project will elucidate deficits in learning semantic information in developmental language disorder (DLD, formerly referred to as specific language impairment) by combining behavioral and neural measures to examine differences in the semantic learning process between school-age children with and without DLD. Vocabulary knowledge, particularly semantic knowledge, has a critical influence on reading comprehension and academic success. Despite the strong association between vocabulary knowledge and academic success, vocabulary is an under-recognized area of deficit in school-age children with DLD. Younger children with DLD have well-established deficits in vocabulary and word learning and weaknesses in semantic knowledge. Additionally, the rate of vocabulary growth in children with DLD decreases compared to typically developing peers around age 10 and semantic representations of known vocabulary items are sparse. Even with this knowledge, the field's ability to make progress toward improved semantic learning in school age DLD is hindered by the lack of basic information on the underlying nature of the semantic learning deficits in this population. This project establishes how and why semantic learning differs between school-age children with and without DLD, providing a much-needed theoretical foundation for clinical research.

Storkel, expanding on an adult word learning model by Leach and Samuel, provides a clearly testable account of word learning that has been used with children with DLD. This account involves three processes: 1) triggering, in which a new lexical encounter is compared to existing lexical representations, 2) configuration, which adds information to the expanding lexical representation, and 3) engagement, which examines how the new lexical representation behaves dynamically with existing representations. The configuration process is arguably the most critical for semantic development. Successful configuration requires the simultaneous engagement of cognitive and linguistic processes, such as attention, inhibition, working memory, and semantic and syntactic processing. While it is widely accepted that configuration is the most affected word learning process in DLD, what is unknown is what underlies deficits in configuration and whether these deficits vary across the DLD profile. These questions are further compounded by difficulty measuring configuration and associated processes, given that they are largely internal, and therefore invisible. Electroencephalography (EEG) addresses this invisibility problem by allowing for a real-time examination of unconscious levels of semantic learning and cognitive and linguistic processes. A combined EEG-behavioral methods approach can illustrate how children with DLD are approaching configuration in terms of the relative contribution of these processes. The central hypothesis of this research is that children with DLD engage cognitive and linguistic processes at different points during configuration compared to their typical peers, resulting in poorer semantic learning outcomes.

To test the central hypothesis, the investigators will record behavioral and EEG data from 10-12 year old children with DLD and typical-language peers as they complete a semantic learning task. This age aligns with the point where vocabulary growth rates in DLD further diverge from typical peers [6]. In the semantic learning task, children listen to sets of three sentences that all end with the same nonword: half of the sentence triplets support learning meaning of the nonword, half do not. The investigators will analyze EEG data for event-related potentials (ERPs) as well as changes in neural oscillations (time frequency analysis). The investigators will combine EEG and behavioral measures to examine the following aims:

Aim 1. To investigate the cognitive and linguistic processes underlying configuration in children with DLD and typical language (TL) peers. This aim will include data from the semantic learning task. Based on the assessment of behavioral outcomes, the investigators predict that the TL group will be more accurate in semantic learning than the DLD group. ERP analyses will focus on the N400 component, associated with semantic processing. Time frequency analysis will focus on changes in the theta (4-8 Hz) and alpha (8-12 Hz) frequency bands, typically associated with lexical retrieval and attention/inhibition, respectively. For both neural measures, the investigators predict engagement of the same components (N400, theta, alpha) across groups but different patterns of change in those components during configuration between groups.

Aim 2. To investigate individual differences in configuration in children with DLD and TL peers. This aim will include data from the semantic learning task and a behavioral assessment battery. Assessment of behavioral data will focus the types of errors children make during semantic learning. The investigators expect that children with DLD will provide incorrect meanings for the nonword that best fit with the first sentence in the triplet and that TL children will provide incorrect meanings that best fit with the last sentence. The investigators will also examine individual differences related to semantic learning outcomes and fine-grained differences in N400 learning effects across groups. Here, the investigators expect that individual differences in general language ability and semantic knowledge, measured via the behavioral assessment battery, will be most predictive of both behavioral semantic learning and N400 change during learning.

02

Conditions studied

  • Developmental Language Disorder

Keywords

  • Semantic Learning
  • ERP
  • N400
  • ERSP
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's enrollment of 167 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

San Diego State University is the lead sponsor of 149 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • history of typical language development or history of language or literacy difficulties
  • must be willing to wear EEG cap
  • must be able to sit still for 1.5 hours to complete experimental tasks
  • must be literate

Exclusion criteria

Exclusion Criteria:

  • neurological disorders (i.e., ASD, ADHD)
  • significant neurological history (i.e., head injury, epilepsy)
  • left handedness
  • primary language other than English
  • medication other than over-the-counter allergy medications
  • and/or nonverbal IQ less than 70
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    Developmental language disorder

    Children with language impairment but in the absence of cognitive deficits

    Other: semantic learning

  • Active comparator
    Typical language

    Children with typical language development and typical cognitive development

    Other: semantic learning

Interventions

  • Othersemantic learning

    Experimental semantic learning from linguistic context task

06

What researchers measure

Primary outcomes

  1. Mean Percent Correct Semantic Meaning Identification

    Accuracy on the semantic learning task. Did they correctly identify when there was a meaning or did they say there was no meaning when there should have been one (incorrect response) Higher is better outcome

    Time frame: immediately following treatment, on the same day as treatment, within 30 minutes

  2. N400 Amplitude - Sentence 1

    Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 1 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    Time frame: immediately following treatment, on the same day as treatment, within 30 minutes

  3. Theta Changes

    Changes in theta band activity (measured in hertz) from sentence 1 to sentence 3, time locked to the final word in the sentence. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    Time frame: immediately following treatment, on the same day as treatment, within 30 minutes

  4. N400 Amplitude - Sentence 2

    Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 2 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    Time frame: immediately following treatment, on the same day as treatment, within 30 minutes

  5. N400 Amplitude - Sentence 3

    Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 3 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    Time frame: immediately following treatment, on the same day as treatment, within 30 minutes

Secondary outcomes

  1. General Language Level

    Full measure title: Clinical Evaluation of Language Fundamentals - 5th edition Standardized language omnibus measure Raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 80 is considered in the sub-clinical range indicating the presence of a language disorder

    Time frame: baseline

  2. Nonverbal Cognition

    Full measure title: Wechsler Intelligence Scale for Children - 5th edition Nonverbal index subtests administered, considered the nonverbal subscale For the nonverbal subscale, raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 70 is considered in the sub-clinical range indicating the presence of intellectual disability

    Time frame: baseline

  3. Nonword Repetition Task

    experimental task gauging phonological memory

    Time frame: baseline

07

Results

Posted Dec 13, 2024

Participant flow

Participants were recruited from online sources (e.g., Craiglist, Facebook groups), word of mouth, clinical sites (on-campus Clinic, private clinics), local public schools, and the local University.

Participant flow — Overall Study
MilestoneDevelopmental Language DisorderTypical Language Children
Started1597
Completed1380
Not completed217
Withdrew: Lack of efficacy215
Withdrew: Withdrawal by subject02

Outcome measures

PrimaryMean Percent Correct Semantic Meaning Identification

Accuracy on the semantic learning task. Did they correctly identify when there was a meaning or did they say there was no meaning when there should have been one (incorrect response) Higher is better outcome

Time frame:
immediately following treatment, on the same day as treatment, within 30 minutes
Reported as:
Mean · percentage of correct responses
Mean Percent Correct Semantic Meaning Identification
percentage of correct responsesDevelopmental Language DisorderTypical Language Children
Meaning condition accuracy73.6 ± 16.475.12 ± 14.7
No meaning condition accuracy77.1 ± 19.582.3 ± 15.2
Statistical analysis
  • Developmental Language Disorder vs Typical Language Children · t-test, 1 sided · p = 0.36
PrimaryN400 Amplitude - Sentence 1

Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 1 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Time frame:
immediately following treatment, on the same day as treatment, within 30 minutes
Reported as:
Mean · microvolts
N400 Amplitude - Sentence 1
microvoltsDevelopmental Language DisorderTypical Language
N400 Amplitude - Sentence 1-.1 ± .002-.27 ± .0045
Statistical analysis
  • Developmental Language Disorder vs Typical Language · ANOVA · p = <0.05 (reported p-value was calculated, is not indicating the threshold for statistical significance.)
PrimaryTheta Changes

Changes in theta band activity (measured in hertz) from sentence 1 to sentence 3, time locked to the final word in the sentence. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Time frame:
immediately following treatment, on the same day as treatment, within 30 minutes
Reported as:
Mean · Hertz
Theta Changes
HertzDevelopmental Language DisorderTypical Language
Theta Changes.0521 ± .478.121 ± .21
Statistical analysis
  • Developmental Language Disorder vs Typical Language · ANOVA · p = <0.05 (reported p-value was calculated, is not indicating the threshold for statistical significance.)
PrimaryN400 Amplitude - Sentence 2

Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 2 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Time frame:
immediately following treatment, on the same day as treatment, within 30 minutes
Reported as:
Mean · microvolts
N400 Amplitude - Sentence 2
microvoltsDevelopmental Language DisorderTypical Language
N400 Amplitude - Sentence 2-0.1 ± 0.0050.075 ± 0.003
Statistical analysis
  • Developmental Language Disorder vs Typical Language · ANOVA · p = <0.05 (reported p-value was calculated, is not indicating the threshold for statistical significance.)
PrimaryN400 Amplitude - Sentence 3

Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 3 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Time frame:
immediately following treatment, on the same day as treatment, within 30 minutes
Reported as:
Mean · microvolts
N400 Amplitude - Sentence 3
microvoltsDevelopmental Language DisorderTypical Language
N400 Amplitude - Sentence 30.221 ± .004.662 ± 0.07
Statistical analysis
  • Developmental Language Disorder vs Typical Language · ANOVA · p = <0.05 (reported p-value was calculated, is not indicating the threshold for statistical significance.)
SecondaryGeneral Language Level

Full measure title: Clinical Evaluation of Language Fundamentals - 5th edition Standardized language omnibus measure Raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 80 is considered in the sub-clinical range indicating the presence of a language disorder

Time frame:
baseline
Reported as:
Mean · t-score
General Language Level
t-scoreDevelopmental Language DisorderTypical Language Children
General Language Level73.2 ± 11.6110.9 ± 11.86
Statistical analysis
  • Developmental Language Disorder vs Typical Language Children · t-test, 1 sided · p = <0.00001 (reported p-value was calculated, is not indicating the threshold for statistical significance.)
SecondaryNonverbal Cognition

Full measure title: Wechsler Intelligence Scale for Children - 5th edition Nonverbal index subtests administered, considered the nonverbal subscale For the nonverbal subscale, raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 70 is considered in the sub-clinical range indicating the presence of intellectual disability

Time frame:
baseline
Reported as:
Mean · T-score
Nonverbal Cognition
T-scoreDevelopmental Language DisorderTypical Language Children
Nonverbal Cognition86.2 ± 11.2106.93 ± 12.3
Statistical analysis
  • Developmental Language Disorder vs Typical Language Children · t-test, 1 sided · p = <0.00001 (reported p-value was calculated, is not indicating the threshold for statistical significance.)
SecondaryNonword Repetition Task

experimental task gauging phonological memory

Time frame:
baseline
Reported as:
Mean · percent consonants correct
Nonword Repetition Task
percent consonants correctDevelopmental Language DisorderTypical Language Children
Nonword Repetition Task83.9 ± 9.692.9 ± 5.3
Statistical analysis
  • Developmental Language Disorder vs Typical Language Children · t-test, 1 sided · p = <0.00001 (reported p-value was calculated, is not indicating the threshold for statistical significance.)

Adverse events

Collected over 4 hour data collection for each participant. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Developmental Language Disorder0/15 (0%)0/15 (0%)0/15 (0%)
Typical Language Children0/97 (0%)0/97 (0%)0/97 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Developmental Language DisorderTypical Language ChildrenTotal
<=18 years1597112
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Developmental Language DisorderTypical Language ChildrenTotal
Mean10 ± 1.6911.7 ± 2.5311.54 ± 2.54
Sex: Female, Male
Sex: Female, Male(Participants)Developmental Language DisorderTypical Language ChildrenTotal
Female55055
Male104757
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Developmental Language DisorderTypical Language ChildrenTotal
Hispanic or Latino41418
Not Hispanic or Latino43943
Unknown or Not Reported74451
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Developmental Language DisorderTypical Language ChildrenTotal
American Indian or Alaska Native000
Asian044
Native Hawaiian or Other Pacific Islander000
Black or African American077
White42428
More than one race31316
Unknown or Not Reported84957
Region of Enrollment
Region of Enrollment(participants)Developmental Language DisorderTypical Language ChildrenTotal
United States1597112
08

Study locations

1 site
  • San Diego State University
    San Diego, California 92182, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04508699
Responsible party
Alyson Abel Mills (Associate Professor, San Diego State University) — Principal investigator
First posted
Aug 11, 2020
Start date
Oct 31, 2022
Primary completion
May 31, 2023
Completion
Oct 8, 2024
Results posted
Dec 13, 2024
Last update
Dec 13, 2024

Study contacts

Alyson Abel, PhD
principal investigator · San Diego State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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